RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
Aarhus University Hospital
84 participants
Dec 6, 2024
INTERVENTIONAL
Conditions
Summary
The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.
Eligibility
Inclusion Criteria4
- Age ≥18 years
- Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed)
- Insomnia: a score of \>10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder
- Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or \<54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale
Exclusion Criteria10
- Other sleep disorders than insomnia that may confound sleep and/or cognitive function
- Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed)
- Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function
- Shift work
- Pregnancy or maternity leave
- Recurrence of BC or new cancer
- Insufficient Danish proficiency
- Substance abuse that may confound sleep and/or cognitive function
- Previous experience with CBT-I
- Other cancer than breast cancer
Interventions
CBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education
\- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06553235